The Constant Covid Vaccine Manufacturing Quality Problems

Executive Summary

• The covid vaccines have had horrendous quality problems and differences in quality between batches.
• This story has barely been covered.

Introduction

It has been presented that there are no quality problems with various batches of covid vaccines, and this is incorrect, and mRNA vaccines were always challenging to manufacture and store to make them safe for use.

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Problems With Manufacturing Vaccine Quality – Released Through a Computer Hack or Leak

The public was never told about the covid vaccine manufacturing quality only became public knowledge because of a computer hack or leak. And this previously hidden information is there were serious problems with the manufacturing process of the vaccines.

This is covered in the following quotation.

Leaked documents show that some early commercial batches of Pfizer-BioNTech’s covid-19 vaccine had lower than expected levels of intact mRNA, prompting wider questions about how to assess this novel vaccine platform, writes Serena Tinari.

As it conducted its analysis of the Pfizer-BioNTech covid-19 vaccine in December, the European Medicines Agency (EMA) was the victim of a cyberattack. More than 40 megabytes of classified information from the agency’s review were published on the dark web, and several journalists—including from The BMJ—and academics worldwide were sent copies of the leaks. They came from anonymous email accounts and most efforts to interact with the senders were unsuccessful. None of the senders revealed their identity, and the EMA says it is pursuing a criminal investigation. – BMJ

It is curious that those that provide accurate information that was being hidden by the public at an agency funded by the public are being investigated for criminal prosecution. Would this information have ever been published and known if not for the hack?

The European Medicine Agency serves an analogous function to the US FDA. The documents that were leaked show something that pharmaceutical companies and perhaps the EMA do not want anyone to know, as is explained in the following quotation.

EMA Hid Concerns About the Covid Vaccines Quality From the Public?

The BMJ has reviewed the documents, which show that regulators had major concerns over unexpectedly low quantities of intact mRNA in batches of the vaccine developed for commercial production.

EMA scientists tasked with ensuring manufacturing quality—the chemistry, manufacturing, and control aspects of Pfizer’s submission to the EMA—worried about “truncated and modified mRNA species present in the finished product.” Among the many files leaked to The BMJ, an email dated 23 November by a high ranking EMA official outlined a raft of issues. In short, commercial manufacturing was not producing vaccines to the specifications expected, and regulators were unsure of the implications. EMA responded by filing two “major objections” with Pfizer, along with a host of other questions it wanted addressed.

The email identified “a significant difference in % RNA integrity/truncated species” between the clinical batches and proposed commercial batches—from around 78% to 55%. The root cause was unknown and the impact of this loss of RNA integrity on safety and efficacy of the vaccine was “yet to be defined,” the email said.

Ultimately, on 21 December, EMA authorised Pfizer-BioNTech’s vaccine. The agency’s public assessment report, a technical document published on its website, noted, “the quality of this medicinal product, submitted in the emergency context of the current (covid-19) pandemic, is considered to be sufficiently consistent and acceptable.” – BMJ

Note that none of these issues with quality was communicated to the public. The EMA actively deceived the public on this topic.

This is just the introduction to this article. The full article is on the following website.